Skip to main content
Clinical Trials/NCT01418820
NCT01418820
Completed
Phase 2

Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

University of Magdeburg1 site in 1 country32 target enrollmentMarch 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Complete Hemianopia
Sponsor
University of Magdeburg
Enrollment
32
Locations
1
Primary Endpoint
detection accuracy (%) in visual field measures over baseline
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.

It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
December 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Magdeburg
Responsible Party
Principal Investigator
Principal Investigator

Bernhard A. Sabel

Prof. Dr.

University of Magdeburg

Eligibility Criteria

Inclusion Criteria

  • lesion of the tractus opticus or of the visual cortex
  • lesion age \> 6 months
  • stable visual field defect with residual vision

Exclusion Criteria

  • electric or electronic implants, e.g. heart pacer
  • any metal artefacts in the head
  • Auto-immune diseases in acute stage
  • mental diseases, e.g. schizophrenia etc.
  • diabetic retinopathy
  • addictive diseases
  • blood pressure above 160/100 mmHg
  • instable or high level of intraocular pressure above 27 mmHg
  • retinitis pigmentosa
  • pathological nystagmus

Outcomes

Primary Outcomes

detection accuracy (%) in visual field measures over baseline

Time Frame: baseline to 8 weeks after stimulation

visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)

Secondary Outcomes

  • detection accuracy (%) in the intact visual field over baseline(baseline to 8 weeks after stimulation)
  • reaction time (ms)(baseline to 8 weeks after stimulation)
  • EEG parameters(baseline to 8 weeks after stimulation)
  • conventional perimetry(baseline to 8 weeks after stimulation)
  • visual acuity (LogRAD)(baseline to 8 weeks after stimulation)

Study Sites (1)

Loading locations...

Similar Trials